Regulators Take Aim at Genomics

Genomics is an area of information technology that's been growing faster than Moore's law, an exciting development given its potential to transform medicine. That provokes resentment from bureaucrats, because it means they lose some control. However, less government involvement does not automatically mean a loss of safety for consumers.

By Sonia Arrison
Jul 28, 2010 5:00 AM PT

The genomics industry, which provides reports about disease risk, ancestry, and drug reactions based on one's DNA, came under fire last week as a Congressional Committee held
hearings and the Government Accountability Office (GAO) released an unscientific "study" of the sector.

According to undercover discussions with genomics firms, the GAO
reports that "fictitious consumers received test results that are misleading and of little or no practical use." The agency admits, however, that it "did not conduct a scientific study but instead documented observations that could be made by any consumer."

The GAO's "sting" operation on this nascent field looks more like a witch hunt, given that it lumped in legitimate testing companies with others that are not.

Tricky Business

In one instance, a company representative said that it would be OK to send in someone else's saliva to be tested. As the GAO points out, that practice is already restricted in 33 states, so this seems more like a matter of enforcement.

The GAO's report is a tricky way of attempting to perturb the public about genetic testing, but it also raises a key question: Why haven't government regulators disciplined the companies that are clearly breaking the already-established rules?

The GAO also blasts the genomics industry for providing different results for the same DNA, but when dealing with something as complicated as the human body, there often are valid scientific reasons for variation. As 23andMe points out on
its blog, testing is not yet standardized, and some companies "employ different statistical models for making risk estimates; they establish different criteria for the inclusion of associations in their reports; and new associations are being discovered at a faster rate than companies' development cycles."

Incomplete Pictures

This lack of standardization is something the industry clearly needs to address, but it's not a problem confined to genomics. For example, the
Reynolds Risk Score and the
National Cholesterol Education Program are both scientifically valid, and both received federal funds to calculate cardiovascular risk. Yet they offer different answers for the same individual, without provoking a federal regulatory reaction.

Another complaint against genomics firms is that the tests are incomplete for people not of European ancestry since the data needed has not been collected yet. This is true, and it is a problem that legitimate genomic companies are working on, as are other researchers in areas such as breast cancer, where information for Hispanics is not yet as
complete as information for African Americans and whites.

It appears that most of the problems in the genomics industry stem from government failure to enforce existing laws and the reality that the industry is still collecting the data needed to both standardize and include all groups. Why, one wonders, has genomics been singled out for special attention?

Politicization of Science

According to genomics expert Daniel MacArthur, the GAO's report and Congressional hearings are worrisome for those who look forward to a bright future in personalized medicine.

"The FDA is clearly angling to exert its control over a much broader range of tests, meaning its regulatory claws will likely sink into thousands of small nonprofit labs performing custom diagnostics for rare diseases, as well as startups seeking to build new technologies for genetic testing," he says. "The suffocating effects of this power-grab will be felt well beyond our little circle of personal genomics aficionados."

Genomics is an area of information technology that's been growing faster than Moore's law, an exciting development given its potential to transform medicine. That provokes resentment from bureaucrats, because it means they lose some control. However, less government involvement does not automatically mean a loss of safety for consumers. Legitimate companies are working hard to provide the best data they can, and it's not that difficult to sort the bad actors from the good. Even the mighty GAO saw fit to document "observations that could be made by any consumer."

Government does have a role to play in stopping unscrupulous firms from outright lying, as one did when it told undercover GAO agents that Lance Armstrong endorsed its product when he did not. As to whether individuals should be able to get information about their own bodies from legitimate genomics firms, the answer is clear.

Consumers have every right to see their own genetic data and learn about the most recent scientific information, even if that information is not absolutely complete. The bigger concern here is the political treatment of science. On this theme, everybody should be watching Big Brother very carefully.